ID

4904

Description

ODM derived from http://clinicaltrials.gov/show/NCT00331890

Link

http://clinicaltrials.gov/show/NCT00331890

Keywords

Versions (2)
  1. 12/11/13 12/11/13 - Martin Dugas
  2. 4/14/14 4/14/14 - Julian Varghese
Uploaded on

April 14, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00331890 Acute Stroke. Cerebral Infarction.

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
Patient, >18 years old
Description

age >18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Patients must be treated within 24 hours of their initial stroke symptoms onset.
Description

Patients must be treated within 24 hours of their initial stroke symptoms onset.

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0205265
SNOMED CT 2011_0131
884001
UMLS CUI 2011AA
C0038454
SNOMED CT 2011_0131
230690007
MedDRA 14.1
10042244
ICD-10-CM Version 2010
I63.9
CTCAE 1105E
E12826
UMLS CUI 2011AA
C1457887
LOINC Version 232
MTHU021540
ICD-9-CM Version 2011
780-789.99
UMLS CUI 2011AA
C0332162
SNOMED CT 2011_0131
77374008
Patients with a measurable focal neurological deficit lasting for a minimum of 60 minutes.
Description

Patients with a measurable focal neurological deficit lasting for a minimum of 60 minutes.

Data type

boolean

Alias
UMLS CUI 2011AA
C1513040
UMLS CUI 2011AA
C0205234
SNOMED CT 2011_0131
87017008
UMLS CUI 2011AA
C0521654
SNOMED CT 2011_0131
264552009
Patients must have a CT scan and/or conventional MRI compatible with the clinical diagnosis of acute ischemic stroke prior to being randomized.
Description

Patients must have a CT scan and/or conventional MRI compatible with the clinical diagnosis of acute ischemic stroke prior to being randomized.

Data type

boolean

Alias
UMLS CUI 2011AA
C0040405
MedDRA 14.1
10011603
UMLS CUI 2011AA
C0439858
SNOMED CT 2011_0131
255333006
UMLS CUI 2011AA
C0024485
SNOMED CT 2011_0131
113091000
MedDRA 14.1
10028049
UMLS CUI 2011AA
C1524057
SNOMED CT 2011_0131
7883008
UMLS CUI 2011AA
C0332140
SNOMED CT 2011_0131
39154008
UMLS CUI 2011AA
C0205178
SNOMED CT 2011_0131
272118002
UMLS CUI 2011AA
C0948008
SNOMED CT 2011_0131
422504002
MedDRA 14.1
10055221
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
Patients must have an acute ischemic stroke referable to the middle cerebral artery territory
Description

Patients must have an acute ischemic stroke referable to the middle cerebral artery territory

Data type

boolean

Alias
UMLS CUI 2011AA
C0205178
SNOMED CT 2011_0131
272118002
UMLS CUI 2011AA
C0948008
SNOMED CT 2011_0131
422504002
MedDRA 14.1
10055221
UMLS CUI 2011AA
C1269012
SNOMED CT 2011_0131
181312002
At inclusion, NIHSS score > 7, with at least 2 of these points from sections 5 & 6 (motor)
Description

At inclusion, NIHSS score > 7, with at least 2 of these points from sections 5 & 6 (motor)

Data type

boolean

Alias
UMLS CUI 2011AA
CL425202
UMLS CUI 2011AA
C1697238
MedDRA 14.1
10065527
UMLS CUI 2011AA
C1697239
MedDRA 14.1
10065528
UMLS CUI 2011AA
C0260026
UMLS CUI 2011AA
C1140618
SNOMED CT 2011_0131
53120007
LOINC Version 232
MTHU011974
UMLS CUI 2011AA
C0023216
SNOMED CT 2011_0131
61685007
LOINC Version 232
MTHU011970
Immediately (i.e. minutes) pre-stroke, MRS < 2
Description

Immediately (i.e. minutes) pre-stroke, MRS < 2

Data type

boolean

Alias
UMLS CUI 2011AA
C0205253
SNOMED CT 2011_0131
88694003
UMLS CUI 2011AA
C0038454
SNOMED CT 2011_0131
230690007
MedDRA 14.1
10042244
ICD-10-CM Version 2010
I63.9
CTCAE 1105E
E12826
UMLS CUI 2011AA
CL423500
Women of childbearing potential must have a negative pregnancy test prior to enrolment
Description

Women of childbearing potential must have a negative pregnancy test prior to enrolment

Data type

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0427780
SNOMED CT 2011_0131
250425007
MedDRA 14.1
10036574
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1516879
Signed informed consent
Description

Signed informed consent

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Patients in coma: patients having a score of >=2 in the items regarding the level of consciousness in the NIHSS (1a)
Description

Patients in coma: patients having a score of >=2 in the items regarding the level of consciousness in the NIHSS (1a)

Data type

boolean

Alias
UMLS CUI 2011AA
C0009421
SNOMED CT 2011_0131
371632003
MedDRA 14.1
10010071
LOINC Version 232
MTHU020645
ICD-10-CM Version 2010
R40.20
ICD-9-CM Version 2011
780.01
UMLS CUI 2011AA
C1697239
MedDRA 14.1
10065528
UMLS CUI 2011AA
CL414978
UMLS CUI 2011AA
C0234425
SNOMED CT 2011_0131
6942003
CT or conventional MRI evidence of brain tumor, cerebral edema with a clinically significant mass midline shift with compression of the ventricles, brainstem or cerebellar infarction, subarachnoid and/or intracerebral and/or intraventricular hemorrhage
Description

CT or conventional MRI evidence of brain tumor, cerebral edema with a clinically significant mass midline shift with compression of the ventricles, brainstem or cerebellar infarction, subarachnoid and/or intracerebral and/or intraventricular hemorrhage

Data type

boolean

Alias
UMLS CUI 2011AA
C0040405
MedDRA 14.1
10011603
UMLS CUI 2011AA
C0439858
SNOMED CT 2011_0131
255333006
UMLS CUI 2011AA
C0024485
SNOMED CT 2011_0131
113091000
MedDRA 14.1
10028049
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0006118
SNOMED CT 2011_0131
126952004
MedDRA 14.1
10061019
ICD-9-CM Version 2011
239.6
UMLS CUI 2011AA
C0006114
SNOMED CT 2011_0131
2032001
MedDRA 14.1
10008107
ICD-10-CM Version 2010
G93.6
ICD-9-CM Version 2011
348.5
CTCAE 1105E
E12650
UMLS CUI 2011AA
C0576481
SNOMED CT 2011_0131
299728009
MedDRA 14.1
10069551
UMLS CUI 2011AA
C0577559
SNOMED CT 2011_0131
4147007
MedDRA 14.1
10026865
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0332459
SNOMED CT 2011_0131
71173004
UMLS CUI 2011AA
C0007799
SNOMED CT 2011_0131
35764002
LOINC Version 232
MTHU024384
UMLS CUI 2011AA
C0521542
SNOMED CT 2011_0131
95457000
MedDRA 14.1
10006147
UMLS CUI 2011AA
C0236073
SNOMED CT 2011_0131
95460007
MedDRA 14.1
10008034
UMLS CUI 2011AA
C0038525
SNOMED CT 2011_0131
21454007
MedDRA 14.1
10042316
ICD-9-CM Version 2011
430
UMLS CUI 2011AA
C2937358
SNOMED CT 2011_0131
274100004
MedDRA 14.1
10008111
ICD-9-CM Version 2011
431
UMLS CUI 2011AA
C0240059
SNOMED CT 2011_0131
23276006
MedDRA 14.1
10022840
History of ventricular dysrhythmias, acute myocardial infarction within 72 hours prior to enrolment, unstable angina, decompensated congestive heart failure or any other acute, severe, uncontrollable or sustained cardiovascular condition that, in the Investigator's opinion, may interfere with effective participation in the study
Description

History of ventricular dysrhythmias, acute myocardial infarction within 72 hours prior to enrolment, unstable angina, decompensated congestive heart failure or any other acute, severe, uncontrollable or sustained cardiovascular condition that, in the Investigator's opinion, may interfere with effective participation in the study

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0085612
SNOMED CT 2011_0131
44103008
MedDRA 14.1
10047281
ICD-10-CM Version 2010
I49.01
CTCAE 1105E
E10230
UMLS CUI 2011AA
C0155626
SNOMED CT 2011_0131
57054005
MedDRA 14.1
10000891
ICD-10-CM Version 2010
I21
ICD-9-CM Version 2011
410
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C0002965
SNOMED CT 2011_0131
4557003
MedDRA 14.1
10002388
ICD-10-CM Version 2010
I20.0
ICD-9-CM Version 2011
411.1
UMLS CUI 2011AA
C0205434
SNOMED CT 2011_0131
5650002
UMLS CUI 2011AA
C0018802
SNOMED CT 2011_0131
42343007
MedDRA 14.1
10007559
LOINC Version 232
MTHU020787
ICD-10-CM Version 2010
I50.9
ICD-9-CM Version 2011
428.0
UMLS CUI 2011AA
C0007222
SNOMED CT 2011_0131
105980002
MedDRA 14.1
10007649
ICD-9-CM Version 2011
429.2
UMLS CUI 2011AA
C0205178
SNOMED CT 2011_0131
272118002
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0443318
SNOMED CT 2011_0131
263892007
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C1704419
SNOMED CT 2011_0131
254648000
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Previous disorders that may confound the interpretation of the neurological scales
Description

Previous disorders that may confound the interpretation of the neurological scales

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0459471
SNOMED CT 2011_0131
280452008
LOINC Version 232
MTHU003869
UMLS CUI 2011AA
C0205494
SNOMED CT 2011_0131
1199008
LOINC Version 232
MTHU031871
UMLS CUI 2011AA
C0349674
SNOMED CT 2011_0131
278111002
Drug addiction-related disorders
Description

Drug addiction-related disorders

Data type

boolean

Alias
UMLS CUI 2011AA
C1510472
SNOMED CT 2011_0131
191816009
MedDRA 14.1
10013663
ICD-9-CM Version 2011
304
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
Pre existing dementia, when dementia implies a disability, measured as an score of >=2 in the previous MRS
Description

Pre existing dementia, when dementia implies a disability, measured as an score of >=2 in the previous MRS

Data type

boolean

Alias
UMLS CUI 2011AA
C2347662
UMLS CUI 2011AA
C0497327
SNOMED CT 2011_0131
52448006
MedDRA 14.1
10012267
ICD-10-CM Version 2010
F03
ICD-9-CM Version 2011
290
UMLS CUI 2011AA
C0231170
SNOMED CT 2011_0131
21134002
MedDRA 14.1
10013050
HL7 V3 2006_05
DIS
UMLS CUI 2011AA
C0449820
SNOMED CT 2011_0131
246262008
LOINC Version 232
MTHU024701
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
CL423500
Pre existing medical condition that, in the Investigator's opinion, may interfere with the patient's suitability and participation in the study
Description

Pre existing medical condition that, in the Investigator's opinion, may interfere with the patient's suitability and participation in the study

Data type

boolean

Alias
UMLS CUI 2011AA
C0262926
SNOMED CT 2011_0131
417662000
LOINC Version 232
MTHU027722
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0679823
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Patients participating in another clinical trial or receiving a non-approved drug (clinical investigational drug) <30 days prior to screening
Description

Patients participating in another clinical trial or receiving a non-approved drug (clinical investigational drug) <30 days prior to screening

Data type

boolean

Alias
UMLS CUI 2011AA
C0679823
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
Patients under current treatment with citicoline
Description

Patients under current treatment with citicoline

Data type

boolean

Alias
UMLS CUI 2011AA
C2827774
UMLS CUI 2011AA
C0010725
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age >18 Years
Item
Patient, >18 years old
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patients must be treated within 24 hours of their initial stroke symptoms onset.
Item
Patients must be treated within 24 hours of their initial stroke symptoms onset.
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
C0205265 (UMLS CUI 2011AA)
884001 (SNOMED CT 2011_0131)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
C0332162 (UMLS CUI 2011AA)
77374008 (SNOMED CT 2011_0131)
Patients with a measurable focal neurological deficit lasting for a minimum of 60 minutes.
Item
Patients with a measurable focal neurological deficit lasting for a minimum of 60 minutes.
boolean
C1513040 (UMLS CUI 2011AA)
C0205234 (UMLS CUI 2011AA)
87017008 (SNOMED CT 2011_0131)
C0521654 (UMLS CUI 2011AA)
264552009 (SNOMED CT 2011_0131)
Patients must have a CT scan and/or conventional MRI compatible with the clinical diagnosis of acute ischemic stroke prior to being randomized.
Item
Patients must have a CT scan and/or conventional MRI compatible with the clinical diagnosis of acute ischemic stroke prior to being randomized.
boolean
C0040405 (UMLS CUI 2011AA)
10011603 (MedDRA 14.1)
C0439858 (UMLS CUI 2011AA)
255333006 (SNOMED CT 2011_0131)
C0024485 (UMLS CUI 2011AA)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
C1524057 (UMLS CUI 2011AA)
7883008 (SNOMED CT 2011_0131)
C0332140 (UMLS CUI 2011AA)
39154008 (SNOMED CT 2011_0131)
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0948008 (UMLS CUI 2011AA)
422504002 (SNOMED CT 2011_0131)
10055221 (MedDRA 14.1)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Patients must have an acute ischemic stroke referable to the middle cerebral artery territory
Item
Patients must have an acute ischemic stroke referable to the middle cerebral artery territory
boolean
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0948008 (UMLS CUI 2011AA)
422504002 (SNOMED CT 2011_0131)
10055221 (MedDRA 14.1)
C1269012 (UMLS CUI 2011AA)
181312002 (SNOMED CT 2011_0131)
At inclusion, NIHSS score > 7, with at least 2 of these points from sections 5 & 6 (motor)
Item
At inclusion, NIHSS score > 7, with at least 2 of these points from sections 5 & 6 (motor)
boolean
CL425202 (UMLS CUI 2011AA)
C1697238 (UMLS CUI 2011AA)
10065527 (MedDRA 14.1)
C1697239 (UMLS CUI 2011AA)
10065528 (MedDRA 14.1)
C0260026 (UMLS CUI 2011AA)
C1140618 (UMLS CUI 2011AA)
53120007 (SNOMED CT 2011_0131)
MTHU011974 (LOINC Version 232)
C0023216 (UMLS CUI 2011AA)
61685007 (SNOMED CT 2011_0131)
MTHU011970 (LOINC Version 232)
Immediately (i.e. minutes) pre-stroke, MRS < 2
Item
Immediately (i.e. minutes) pre-stroke, MRS < 2
boolean
C0205253 (UMLS CUI 2011AA)
88694003 (SNOMED CT 2011_0131)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
CL423500 (UMLS CUI 2011AA)
Women of childbearing potential must have a negative pregnancy test prior to enrolment
Item
Women of childbearing potential must have a negative pregnancy test prior to enrolment
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0427780 (UMLS CUI 2011AA)
250425007 (SNOMED CT 2011_0131)
10036574 (MedDRA 14.1)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
Signed informed consent
Item
Signed informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Patients in coma: patients having a score of >=2 in the items regarding the level of consciousness in the NIHSS (1a)
Item
Patients in coma: patients having a score of >=2 in the items regarding the level of consciousness in the NIHSS (1a)
boolean
C0009421 (UMLS CUI 2011AA)
371632003 (SNOMED CT 2011_0131)
10010071 (MedDRA 14.1)
MTHU020645 (LOINC Version 232)
R40.20 (ICD-10-CM Version 2010)
780.01 (ICD-9-CM Version 2011)
C1697239 (UMLS CUI 2011AA)
10065528 (MedDRA 14.1)
CL414978 (UMLS CUI 2011AA)
C0234425 (UMLS CUI 2011AA)
6942003 (SNOMED CT 2011_0131)
CT or conventional MRI evidence of brain tumor, cerebral edema with a clinically significant mass midline shift with compression of the ventricles, brainstem or cerebellar infarction, subarachnoid and/or intracerebral and/or intraventricular hemorrhage
Item
CT or conventional MRI evidence of brain tumor, cerebral edema with a clinically significant mass midline shift with compression of the ventricles, brainstem or cerebellar infarction, subarachnoid and/or intracerebral and/or intraventricular hemorrhage
boolean
C0040405 (UMLS CUI 2011AA)
10011603 (MedDRA 14.1)
C0439858 (UMLS CUI 2011AA)
255333006 (SNOMED CT 2011_0131)
C0024485 (UMLS CUI 2011AA)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0006118 (UMLS CUI 2011AA)
126952004 (SNOMED CT 2011_0131)
10061019 (MedDRA 14.1)
239.6 (ICD-9-CM Version 2011)
C0006114 (UMLS CUI 2011AA)
2032001 (SNOMED CT 2011_0131)
10008107 (MedDRA 14.1)
G93.6 (ICD-10-CM Version 2010)
348.5 (ICD-9-CM Version 2011)
E12650 (CTCAE 1105E)
C0576481 (UMLS CUI 2011AA)
299728009 (SNOMED CT 2011_0131)
10069551 (MedDRA 14.1)
C0577559 (UMLS CUI 2011AA)
4147007 (SNOMED CT 2011_0131)
10026865 (MedDRA 14.1)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0332459 (UMLS CUI 2011AA)
71173004 (SNOMED CT 2011_0131)
C0007799 (UMLS CUI 2011AA)
35764002 (SNOMED CT 2011_0131)
MTHU024384 (LOINC Version 232)
C0521542 (UMLS CUI 2011AA)
95457000 (SNOMED CT 2011_0131)
10006147 (MedDRA 14.1)
C0236073 (UMLS CUI 2011AA)
95460007 (SNOMED CT 2011_0131)
10008034 (MedDRA 14.1)
C0038525 (UMLS CUI 2011AA)
21454007 (SNOMED CT 2011_0131)
10042316 (MedDRA 14.1)
430 (ICD-9-CM Version 2011)
C2937358 (UMLS CUI 2011AA)
274100004 (SNOMED CT 2011_0131)
10008111 (MedDRA 14.1)
431 (ICD-9-CM Version 2011)
C0240059 (UMLS CUI 2011AA)
23276006 (SNOMED CT 2011_0131)
10022840 (MedDRA 14.1)
History of ventricular dysrhythmias, acute myocardial infarction within 72 hours prior to enrolment, unstable angina, decompensated congestive heart failure or any other acute, severe, uncontrollable or sustained cardiovascular condition that, in the Investigator's opinion, may interfere with effective participation in the study
Item
History of ventricular dysrhythmias, acute myocardial infarction within 72 hours prior to enrolment, unstable angina, decompensated congestive heart failure or any other acute, severe, uncontrollable or sustained cardiovascular condition that, in the Investigator's opinion, may interfere with effective participation in the study
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0085612 (UMLS CUI 2011AA)
44103008 (SNOMED CT 2011_0131)
10047281 (MedDRA 14.1)
I49.01 (ICD-10-CM Version 2010)
E10230 (CTCAE 1105E)
C0155626 (UMLS CUI 2011AA)
57054005 (SNOMED CT 2011_0131)
10000891 (MedDRA 14.1)
I21 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
C0002965 (UMLS CUI 2011AA)
4557003 (SNOMED CT 2011_0131)
10002388 (MedDRA 14.1)
I20.0 (ICD-10-CM Version 2010)
411.1 (ICD-9-CM Version 2011)
C0205434 (UMLS CUI 2011AA)
5650002 (SNOMED CT 2011_0131)
C0018802 (UMLS CUI 2011AA)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0443318 (UMLS CUI 2011AA)
263892007 (SNOMED CT 2011_0131)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C1704419 (UMLS CUI 2011AA)
254648000 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Previous disorders that may confound the interpretation of the neurological scales
Item
Previous disorders that may confound the interpretation of the neurological scales
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0459471 (UMLS CUI 2011AA)
280452008 (SNOMED CT 2011_0131)
MTHU003869 (LOINC Version 232)
C0205494 (UMLS CUI 2011AA)
1199008 (SNOMED CT 2011_0131)
MTHU031871 (LOINC Version 232)
C0349674 (UMLS CUI 2011AA)
278111002 (SNOMED CT 2011_0131)
Drug addiction-related disorders
Item
Drug addiction-related disorders
boolean
C1510472 (UMLS CUI 2011AA)
191816009 (SNOMED CT 2011_0131)
10013663 (MedDRA 14.1)
304 (ICD-9-CM Version 2011)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
Pre existing dementia, when dementia implies a disability, measured as an score of >=2 in the previous MRS
Item
Pre existing dementia, when dementia implies a disability, measured as an score of >=2 in the previous MRS
boolean
C2347662 (UMLS CUI 2011AA)
C0497327 (UMLS CUI 2011AA)
52448006 (SNOMED CT 2011_0131)
10012267 (MedDRA 14.1)
F03 (ICD-10-CM Version 2010)
290 (ICD-9-CM Version 2011)
C0231170 (UMLS CUI 2011AA)
21134002 (SNOMED CT 2011_0131)
10013050 (MedDRA 14.1)
DIS (HL7 V3 2006_05)
C0449820 (UMLS CUI 2011AA)
246262008 (SNOMED CT 2011_0131)
MTHU024701 (LOINC Version 232)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
CL423500 (UMLS CUI 2011AA)
Pre existing medical condition that, in the Investigator's opinion, may interfere with the patient's suitability and participation in the study
Item
Pre existing medical condition that, in the Investigator's opinion, may interfere with the patient's suitability and participation in the study
boolean
C0262926 (UMLS CUI 2011AA)
417662000 (SNOMED CT 2011_0131)
MTHU027722 (LOINC Version 232)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Patients participating in another clinical trial or receiving a non-approved drug (clinical investigational drug) <30 days prior to screening
Item
Patients participating in another clinical trial or receiving a non-approved drug (clinical investigational drug) <30 days prior to screening
boolean
C0679823 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Patients under current treatment with citicoline
Item
Patients under current treatment with citicoline
boolean
C2827774 (UMLS CUI 2011AA)
C0010725 (UMLS CUI 2011AA)
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